A new peer-reviewed study published in Cytotherapy, the official journal of the International Society for Cell & Gene Therapy (ISCT), reports early clinical experience using Ossium Health’s organ donor-derived, cryopreserved bone marrow as an off-the-shelf graft source for allogeneic hematopoietic cell transplantation (alloHCT). The study provides the most comprehensive description to date of a fully centralized, GMP-manufactured bone marrow cryopreservation platform, demonstrating that off-the-shelf marrow can be produced at scale with exceptional consistency, long-term stability, and strong clinical performance.

For decades, allogeneic transplantation has relied on fresh grafts from living donors, accepting significant logistical risk, donor attrition, and delays that prevent many patients from ever reaching transplant. Ossium’s approach fundamentally changes that paradigm by offering a high-quality, banked graft source that can be delivered within days rather than months.

The published data highlight Ossium’s extensive cryopreservation validation. By applying novel methods along with manufacturing discipline—rather than center-specific, operator-dependent procedures—Ossium eliminates the variability that has historically plagued cryopreserved allogeneic grafts.

“The COVID-19 pandemic made it clear that cryopreservation is essential, but it also exposed how variable outcomes can be when it’s done inconsistently,” said Erik Woods, PhD, Chief Science Officer, Co-Founder, and EVP of Ossium Health. “What we’ve demonstrated here is that when cryopreservation is engineered, validated, and controlled in a true manufacturing process, you can deliver consistently high-quality bone marrow that performs clinically.”

In the study’s reported clinical experience, three high-risk patients with acute myeloid leukemia (AML) received cryopreserved bone marrow from Ossium through an expanded access program. All patients achieved rapid neutrophil and platelet engraftment, full donor chimerism, and successful immune reconstitution, with no infusion-related toxicity, cytokine release syndrome, or DMSO-related adverse events.

“These results reinforce that Ossium’s cryopreserved marrow is not only logistically superior—it’s biologically potent,” Woods added. “Patients were able to proceed to transplant when they needed it, not when donor logistics allowed, and there were no trade-offs in treatment outcomes.”

By demonstrating that cryopreserved bone marrow can be standardized, stable, and clinically effective, the study challenges the long-held assumption that fresh grafts are inherently superior for alloHCT. Ossium’s platform decouples transplantation from donor scheduling, transportation delays, and attrition—opening the door to faster, more predictable access to life-saving therapy and establishing a new infrastructure model for the field.

About Ossium Health

Ossium Health is a bioengineering company that leverages its proprietary organ donor bone marrow banking platform to develop stem cell therapies for patients with life-threatening hematologic conditions, organ transplant rejection, and musculoskeletal defects. Founded in 2016, the company is led by Kevin Caldwell, Chief Executive Officer, President and Co-Founder, and Erik Woods, Chief Science Officer, Executive Vice President and Co-Founder. Ossium Health’s manufacturing facility is registered with the FDA and its laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA). For more information, please visit https://ossiumhealth.com.

Follow the company on LinkedIn at https://www.linkedin.com/company/ossiumhealth/ and X at https://x.com/ossiumhealth.

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